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UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA MEMORANDUM OPINION AND ORDER DENYING DEFENDANT’S MOTION FOR JUDGMENT AS A MATTER OF LAW
Mikal C. Watts, WATTS LAW FIRM, LLP, 555 North Carancahua, Suite 1400, Corpus Christi, TX 78478; Ronald S. Goldser, ZIMMERMAN REED, PLLP, 651 Nicollet Mall, Suite 501, Minneapolis, MN 55402; and Lewis J. Saul, LEWIS SAUL & ASSOCIATES, 183 Middle Street, Suite 200, Portland, ME 04101, lead counsel for plaintiff Schedin. John Dames and William V. Essig, DRINKER BIDDLE & REATH LLP, 191 North Wacker Drive, Suite 3700, Chicago, IL 60606; William H. Robinson, Jr., LECLAIR RYAN, 1100 Connecticut Avenue N.W., Suite 600, Washington, DC 20036; and Tracy J. Van Steenburgh, NILAN JOHNSON LEWIS, PA, 400 One Financial Plaza, 120 South Sixth Street, Minneapolis, MN 55402, lead counsel for defendant. Plaintiff John Schedin brought claims against defendant Ortho-McNeil-Janssen
Pharmaceuticals, Inc. (“Ortho-McNeil”) for failure to warn about certain risks he was
taking in using its drug, Levaquin, namely tendon rupture. His case was the first case
tried in a larger multi-district litigation involving numerous plaintiffs. The jury found for
Schedin, and defendant has moved for judgment as a matter of law. Ortho-McNeil
argues that Schedin’s failure to warn claims required the jury to return a verdict that is
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inconsistent with, and thus preempted by, federal law, specifically Food and Drug
Administration (“FDA”) regulations made pursuant to the Food, Drug, and Cosmetic Act
(“FDCA”). See, e.g., 21 C.F.R. § 201.57 (requirements on the format and labeling for
prescription drugs). Ortho-McNeil contends that the Levaquin label was approved by the
FDA and was subject to strict guidelines related to changes of labeling that left it unable
to alter the warnings on the drug’s label. Further, Ortho-McNeil argues that Schedin’s
state punitive damages claim is based on “fraud on the FDA” and is therefore similarly
pre-empted. Because the Court finds that Schedin’s state law failure to warn claims are
not preempted by the FDCA, Ortho-McNeil had many options at its disposal to effectuate
an adequate warning, and Schedin’s case does not hinge on a defrauding of the FDA, the
Schedin was prescribed Levaquin for an upper respiratory infection in February
2008 and, after eight days of consuming the drug, suffered bilateral Achilles tendon
ruptures. (Compl. ¶ 108, Docket No. 1.) At the time Schedin was prescribed Levaquin,
the drug contained a warning regarding tendon rupture stating:
Tendon effects: Ruptures of the shoulder, hand, Achilles tendon, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin. Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially in the elderly.
(Def. Ex. 12.) Schedin claims this label alone was inadequate to warn him of the risk he
was taking in using Levaquin, in part because of the way the warning was worded, where
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it was located in the label insert and not easily noticed, and because it did not warn that
Levaquin had higher tendon toxicity than other fluoroquinolones.
At the time Schedin was prescribed Levaquin, it was already subject to class
labeling as a fluoroquinolone, a class of broad-spectrum antibiotics, and the FDA had not
yet mandated a black box warning for the specific injury Schedin suffered.1 Ortho-
McNeil asserts that it could not have instituted a black box warning independently
without an FDA mandate. See 21 C.F.R. § 201.80(e) (“If a boxed warning is required, its
location will be specified by the [FDA].”). Schedin concedes that Ortho-McNeil
probably could not have unilaterally instituted a black box warning. However, he
contends that Ortho-McNeil knew of the risk posed by Levaquin and could have taken
numerous other steps to warn consumers about those risks, such as sending out “Dear
Doctor” letters, having sales representatives meet and confer with doctors, hosting
training seminars, and other such measures to draw attention to the risks. As a result,
Schedin argues his state law claims are not pre-empted by the FDCA.
ANALYSIS STANDARD OF REVIEW
Under Rule 50 of the Federal Rules of Civil Procedure, judgment as a matter of
law is appropriate if no reasonable juror could return a verdict for the nonmoving party.
Weber v. Strippit, Inc., 186 F.3d 907, 912 (8th Cir. 1999). In analyzing a Rule 50 motion,
1 The FDA required just such a black box warning in 2008, which reads:
“Fluoroquinolones, including Levaquin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, [and] in patients taking corticosteroid drugs . . . .” (Levaquin Label 2008.)
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the Court must consider the evidence in the light most favorable to the nonmovant,
resolve all factual conflicts in the nonmovant’s favor, and give the nonmovant the benefit
of all reasonable inferences. Ogden v. Wax Works, Inc., 214 F.3d 999, 1002 (8th Cir.
2000). “[J]udgment as a matter of law is proper when the record contains no proof
beyond speculation to support the verdict.” Heating & Air Specialists, Inc. v. Jones, 180
F.3d 923, 932–33 (8th Cir. 1999) (internal quotation marks omitted).
FAILURE TO WARN CLAIMS Pre-emption Principles
Whether Schedin’s state law failure to warn claims are pre-empted by conflict pre-
emption with federal law is the central question posed by Ortho-McNeil’s motion for
judgment as a matter of law. The Supremacy Clause of the United States Constitution
provides that the “Laws of the United States . . . shall be the supreme Law of the Land.”
U.S. Const. art. VI, cl. 2. The principle of pre-emption is the application of this clause,
resulting in the rule that any “state law that conflicts with federal law is without effect.”
Cipollone v. Liggett Grp., Inc., 505 U.S. 504, 516 (1992) (internal quotation marks
omitted). “Preemption is disfavored in areas of historic importance to the states’ police
powers – areas such as public health and safety.” In re St. Jude Med. Inc. Silzone Heart Valves Prod. Liab. Litig., No. 01-MDL-1396, 2004 WL 45503, at *5 (D. Minn. Jan. 5,
2004) (citing Kemp v. Medtronic, Inc., 231 F.3d 216, 222 (6th Cir. 2000)).
Pre-emption can be either express or implied. Express pre-emption is found when
Congress “pre-empt[s] state law by so stating in express terms.” Hillsborough Cnty., Fla.
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v. Automated Med. Labs, Inc., 471 U.S. 707, 712-13 (1985) (citing Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977)). In addition to express pre-emption, “a court may find
that Congress impliedly preempted such claims by ‘conflict’ if 1) compliance with both
federal and state law is impossible, or 2) the claims would stand as an obstacle to the
accomplishment and execution of the full purposes and objectives of Congress.”
Mensing v. Wyeth, Inc., 588 F.3d 603, 608 (8th Cir. 2009) (alteration and quotation marks
omitted) (citing Crosby v. Nat’l Foreign Trade Council, 530 U.S. 363, 372–73 (2000)),
cert. granted, 78 U.S.L.W. 3522 (U.S. Dec. 10, 2010) (No. 09-993). Therefore, “a
conflict arises when compliance with both federal and state regulations is a physical impossibility . . . .” Automated Med. Labs, Inc.,471 U.S. at 712–13. (emphasis added)
(internal quotations omitted); see also, Mensing, 588 F.3d at 608 (finding no conflict pre-
emption for manufacturers of generic drugs in a state failure to warn action).
“Impossibility pre-emption is a demanding defense.” Wyeth v. Levine, 129 S. Ct. 1187,
1199 (2009). The Supreme Court recently evaluated the FDCA and pre-emption and
described the process by which such determination should be made:
Our answer to [the] question [of pre-emption] must be guided by two cornerstones of our pre-emption jurisprudence. First, the purpose of Congress is the ultimate touchstone in every pre-emption case. Second, in all pre-emption cases, and particularly in those in which Congress has legislated in a field which the States have traditionally occupied, we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.
Wyeth, 129 S. Ct. at 1194–95 (internal citations, alternations, and quotation marks
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Articulating Congress’ purpose in the enactment of and amendments to the FDCA,
[When Congress] enlarged the FDA’s powers to protect the public health and assure the safety, effectiveness, and reliability of drugs, [it] took care to preserve state law. . . . In 2007, . . . Congress . . . granted the FDA statutory authority to require a manufacturer to change its drug label based on safety information that becomes available after a drug’s initial approval. In doing so, however, Congress did not enact a provision in the Senate bill that would have required the FDA to preapprove all changes to drug labels. . . . [T]hrough many amendments to the FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times. Id. at 1196–98 (emphasis added) (internal citations, quotation marks, and alterations
With the Wyeth Court’s interpretation of Congress’ intent in mind, the remaining
question is whether, in the instant case, compliance with both state and federal law
regarding adequate warnings presented Ortho-McNeil a “physical impossibility” such
that state law must yield to the federal law. Automated Med. Labs, Inc., 471 U.S. at 713.
“The question before this court is whether [Ortho-McNeil] can both fulfill a state law
duty to warn and comply with the FDCA. Does federal law forbid [Ortho-McNeil] from
taking steps to warn [its] customers?” Mensing, 588 F.3d at 610–11.
Defendant’s Obligation to Maintain Adequate Warnings
Ortho-McNeil argues that since Levaquin was already subject to an FDA approved
label, FDA regulations would not have permitted Ortho-McNeil to alter the label to
provide stronger warnings. Even if Ortho-McNeil is correct about an inability to
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strengthen the warnings on the label, Ortho-McNeil still had various other options at its
disposal to warn consumers, such as “Dear Doctor” letters, or training by sales
representatives with individual doctors. It could also have proposed an alteration to the
label. As the Eighth Circuit noted in Mensing: “In this case we need not decide whether .
. . manufacturers may unilaterally enhance a label warning . . . because the . . . defendants
could have at least proposed a label change that the FDA could receive and impose . . . if
approved.” Mensing, 588 F.3d at 608 (emphasis original). Given the Supreme Court’s
central holding in Wyeth, that the manufacturer bears responsibility for the content of its
label at all times, the Court is also not convinced that FDA regulations prohibited Ortho-
McNeil from making a label change, let alone from proposing one.
The FDA provides a process whereby a manufacturer can alter or propose an
alteration to an already approved label to reflect new information about a drug. 21 C.F.R.
§ 314.70. “Major changes” require the FDA’s prior approval through a prior approval
supplement. 21 C.F.R. § 314.70(b). Manufacturers may implement “moderate changes,”
including changing a label to strengthen a warning based on newly acquired information,
through a Changes Being Effected (“CBE”) supplement. 21 C.F.R.
§ 314.70(c)(6)(iii)(A)-(D). Manufacturers may implement CBE changes before the FDA
In Wyeth, the defendant claimed that using the CBE process would have rendered
its drug misbranded, in violation of 21 U.S.C. § 352. Wyeth, 129 S. Ct. at 1197. The
Supreme Court disagreed. Rather, the Court held that the statute regarding misbranding
would apply to a drug “that fail[ed] to include ‘adequate warnings.’” Id. (citing 21
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U.S.C. § 352(f) (noting that a drug is misbranded if it does not contain “adequate
warnings against use . . . in such manner and form, as are necessary for the protection of
The Supreme Court noted that the CBE regulation
provides that if a manufacturer is changing a label to “add or strengthen a contraindication, warning, precaution, or adverse reaction” or to “add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product,” it may make the labeling change upon filing its supplemental application with the FDA; it need not wait for FDA approval.
Id. at 1196 (citing 21 C.F.R. § 314.70(c)(6)(iii)(A), (C)).
Ortho-McNeil asserts that the CBE process is not applicable to the instant
litigation, and therefore the holding of Wyeth is inapposite, since Ortho-McNeil could not
have unilaterally instituted a black box warning, could not utilize comparative data in its
labeling of Levaquin, and was bound by class labeling for fluoroquinolones. Ortho-
McNeil argues that these options made it a “physical impossibility” to comply with both
state and federal law therefore it is entitled to judgment at a matter of law. See Automated Med. Labs, Inc., 471 U.S. at 713. Keeping in mind that these were not the
only options available to defendant to warn its consumers, the Court evaluates each of
Black Box Warnings
In the instant case, the FDA ultimately ordered Ortho-McNeil to include a black
box warning about tendon rupture. The FDA requires certain drugs with “[s]pecial
problems, particularly those that may lead to death or serious injury, . . . to [have a
CASE 0:08-cv-05743-JRT Document 196 Filed 03/04/11 Page 9 of 18
warning] placed in a prominently displayed box [a ‘black box’].” 21 C.F.R. § 201.80(e).
Schedin’s experts concede that Ortho-McNeil probably could not have unilaterally
instituted a black box warning. (See, e.g., Aff. of Dana M. Lenahan, Nov. 16, 2010,
Ex. E, at 49–50, Docket No. 150.)2 FDA regulations on black box warnings, while
reserving the inclusion of the black box to the discretion of the FDA, note that a
manufacturer’s “desires about location and wording of boxed warnings, however, will be
considered.” 44 Fed. Reg. 37,434, 37,448 (June 26, 1979). This guidance implies a role
for the manufacturer in the design and content of black box warnings.
Regardless, Ortho-McNeil’s potential inability to unilaterally institute a black box
warning is not a hindrance to state tort liability since it could have instituted other label
changes short of a black box warning or proposed a black box warning instead of waiting
for the FDA to act. Ortho-McNeil points out that the FDA did not institute a black box
warning after requests from citizens’ petitions in 2005, 2006, and 2007. Ortho-McNeil
cites Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. 2010), as support
for the proposition that the FDA’s failure to alter the label in the face of these citizens’
petitions constitutes “clear evidence” that it would not have approved of the change had
Ortho-McNeil proposed it. The Robinson court held that “a court cannot order a drug
company to place on a label a warning if there is ‘clear evidence’ that the FDA would not
approve it.” Id. at 873 (citing Wyeth, 129 S. Ct. at 1198). However, in Robinson the
2 However, Schedin’s expert, Dr. Cheryl Blume, noted there was a recorded instance on
the FDA website of a drug manufacturer utilizing the CBE process to alter or add a black box warning to its labeling. (Lenahan Aff., Ex. E, at 49–50, Docket No. 150.)
CASE 0:08-cv-05743-JRT Document 196 Filed 03/04/11 Page 10 of 18
manufacturer had submitted a proposed label change that the FDA rejected, and the
court cited the “clear evidence” standard as one reason of several to uphold the lower
court’s refusal to allow the plaintiff, on the eve of trial, to add a breach of implied
warranty claim. Id. The Court was not addressing the applicability of failure to warn
claims under state tort law. In contrast, Ortho-McNeil presents no evidence as to what
action the FDA might have taken had Ortho-McNeil proposed or requested a black box
warning. See, e.g., Bartlett v. Mutual Pharm. Co., Inc., No. 08-358, 2010 WL 2889114,
at *9 (D.N.H. July 22, 2010) (discussing and allowing expert testimony regarding the
issue of whether a manufacturer should have requested a black box warning).
Therefore, assuming without deciding that Ortho-McNeil could not have added a
black box warning without FDA approval, it has not demonstrated that it was “physically
impossible” for it to request one from the FDA. Further, instituting a black box warning
was not the only option available to Ortho-McNeil to adequately warn prescribing
doctors. Schedin’s claim are failure to warn claims, not failure to institute a black box
warning claims and as such, Ortho-McNeil’s protestations that it was “physically
impossible” to change its label are both legally inadequate and immaterial.
Ortho-McNeil argues that it could not have altered its label through the CBE
process to include comparative data regarding Levaquin relative to other
fluoroquinolones due to the lack of an “adequate and well-controlled study.” 21 C.F.R.
§ 201.57(c)(2)(iii). Inclusion of comparative information could have alerted physicians
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to the higher tendon toxicity of Levaquin as compared to other fluoroquinolones. The
FDA requires either an “adequate and well-controlled stud[y]” or a waiver from this
requirement when a manufacturer intends to make statements in the “[i]ndications and
usage” section of the label comparing the safety or effectiveness of the drug with other
agents for the same indication. Id. The same regulation notes that to make changes to
the “[w]arnings and precautions” section of the label, such a change should be made “to
include a warning about a clinically significant hazard as soon as there is reasonable evidence of a causal association with a drug; a causal relationship need not have been
definitely established.” 21 C.F.R § 201.57(c)(6)(i) (emphasis added). Conspicuously
absent from the regulation governing the “[w]arnings and precautions” section is a
requirement of adequate and well-controlled studies supporting such warnings.
Here, both parties concede that a “well-controlled study” as defined by the FDA
cannot be conducted ethically since such a study requires a placebo concurrent control
group that could be fatal to elderly patients with respiratory infections. See 21 C.F.R.
§ 314.126(b)(2)(i); (Aff. of Ronald Goldser, July 30, 2010, Ex. B at 31:12 to 36:18, 08-
MDL-1943 Docket No. 1659). Regardless, Ortho-McNeil has presented no evidence that
it applied for a waiver from that requirement as the regulation permits. 21 C.F.R.
Ortho-McNeil similarly presents no case law, and the Court is not aware of any,
distinguishing between the requirements to alter the “[i]ndications and usage” section and
the “[w]arnings and precautions” section, where the comparative information likely
would belong. Courts have compared the “[i]ndications and usage” section of a drug’s
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label to its advertising, indicating that stricter requirements for what manufacturers can
claim in that section are potentially aimed at preventing false advertising. See, e.g.,Proctor & Gamble Pharms., Inc. v. Hoffmann-LaRoche Inc., No. 06-0034, 2006 WL
2588002, at *6–7 (S.D.N.Y. Sept. 6, 2006).
Textual differences between sections within the same statute demonstrate that such
differences may have been intentional. See, e.g., King v. St. Vincent’s Hosp., 502 U.S.
215, 221 n.9 (1991) (discussing the interpretation of congressional intent when presented
with textual differences in the Veterans’ Reemployment Rights Act). Had Congress
intended alterations to the “[w]arnings and precautions” section of a manufacturer’s label
to be subject to the same limitations of an “adequate and well controlled study” as
specified in the “[i]ndications and usage section,” it could have included that language.
Congress did not. Given that the regulations urge a change to the “[w]arnings and
precautions” section “as soon as there is reasonable evidence of a causal association” and
make no mention of “adequate and well-controlled studies” the Court finds support for
the proposition that changes to the “[w]arnings and precautions” section do not require
Additionally, Ortho-McNeil asserts that a manufacturer is under no duty to
provide information about the superiority of other drugs. Ackley v. Wyeth Labs., Inc., 919
F.2d 397, 405 (6th Cir. 1990); Pluto v. Searle Labs., 690 N.E.2d 619, 621 (Ill. Ct. App.
1997). In Pluto, the court held that an Intrauterine Device (“IUD”) manufacturer was not
obligated to disclose that IUD’s posed an “increased risk” of sexually transmitted
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diseases (“STDs”) as compared to other forms of birth control, since the purpose of the
IUD was to prevent pregnancy, not STDs. Pluto, 690 N.E.2d at 621.
In Ackley, the Sixth Circuit upheld summary judgment for a manufacturer of an
“unavoidably unsafe” drug describing the risks posed by that drug. Ackley, 919 F.2d at
405. The court held that such a manufacturer need not discuss alternative medicines in
its label. Id. These cases are distinguishable from the instant case, however, since
information on comparative drugs was germane to the particular condition at issue and
Levaquin has not been classified as “unavoidably unsafe.” See Restatement (Second) of
Torts § 402A(k) (defining unavoidably unsafe products their warnings). Further, while
the Sixth Circuit has adopted the general proposition that a manufacturer is under no duty
to provide information about the superiority of other drugs, it also recognizes the
principle that “[t]he manufacturer is obligated to make a reasonable disclosure of all the
risks inherent in its own drug.” Id.
Therefore, the Court finds that Ortho-McNeil could have submitted the
comparative data3 demonstrating “evidence of a causal association” to the FDA to alter
the “[w]arnings and precautions” section of Levaquin’s label through the CBE process.
At the very least, Ortho-McNeil has not demonstrated “physical impossibility” of the
nature required to satisfy the principles of conflict pre-emption, particularly given its
3 Schedin’s complaint details the many studies comparing the tendon toxicity of Levaquin
with other fluoroquinolones of which Ortho-McNeil was aware as evidenced by the sending of “Dear Doctor” letters in Italy, France, and Belgium — all prior to Schedin’s prescription. (Compl. ¶¶ 30–38, 56–62, Docket No. 1.) The complete studies are included in the record as Exhibits to the Affidavit of Ron Goldser. (Docket No. 1651.)
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burden at this stage of the litigation and taking all inferences in favor of the nonmovant.
Again, as with the black box warning, Schedin’s claims are failure to warn claims,
not failure to provide comparative data claims. Ortho-McNeil had other means by which
it could have warned prescribing physicians of the dangers of Levaquin, even if it was
unable to utilize the comparative data of which it had knowledge to alter its label.
Ortho-McNeil asserts, without reference to statutes or case law, that since
Levaquin was subject to class labeling, it was unable to alter the labeling through the
CBE process to include more adequate warnings about tendon toxicity. Again, the Court
fails to see how this precluded Ortho-McNeil from proposing a label change to the FDA.
Indeed, its own expert testified about numerous other drugs, also subject to class label
requirements, whose labels included information that went beyond the class-required
labeling. (Aff. of Ronald Goldser, Aug. 13, 2010, Ex 1, 08-MDL-1943 Docket
No. 1853.) For example, the drug Floxin has an insomnia warning different from other
drugs in its class. (Id. at 18–19.) The drug Baycol has warnings related to combined use
with other drugs that differs from the class label. (Id. at 185–87.) The same is true for
Paxil (id. at 190–92), Bextra (id. at 193–94), and Ortho-Evra (id. at 195–96). Further,
Schedin notes at least three differences in labeling between Levaquin and other
fluoroquinolones. (Pl.’s Mem. in Opp’n at 11 (Docket No. 157).) Defendant’s expert
concedes that Ortho-McNeil could have used the CBE process despite class labeling.
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(Goldser Aff., Ex. 1 at 18, 08-MDL-1943 (Docket No. 1853).) As a result, the Court
finds that class labeling, at least in practice, creates a floor below which no label in the
class can fall, but does not preclude a manufacturer from including more information in
its label. This finding is consistent with the central holding of Wyeth that “the
manufacturer bears responsibility for the content of its label at all times.” Wyeth, 129 S.
In summation, the Court finds that Ortho-McNeil has not demonstrated “physical
impossibility” as required to satisfy the principles of conflict pre-emption. Even if its
contentions about black box warnings, the inclusion of comparative data, and deviations
from class warnings were accurate, Ortho-McNeil provides no explanation for not
proposing label changes and offers no argument that other methods of warning were
FRAUD ON THE FDA
Ortho-McNeil argues that Schedin’s punitive damages claim amounts to a “fraud
on the FDA” claim, because it is predicated on a finding that Ortho-McNeil misled the
FDA in obtaining and maintaining approval to market Levaquin. In Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341, 348 (2001), the Supreme Court found implied
pre-emption when a plaintiff brought a claim predicated entirely on a theory of fraud on
the FDA because “policing fraud against federal agencies is hardly a field which the
States have traditionally occupied.” 531 U.S. at 347–48 (internal quotation marks
omitted). The Eighth Circuit has opined that Buckman preempts claims where “the
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plaintiff [is] suing because the conduct violates the FDCA . . . .” In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010) (emphasis
original) (internal quotation marks omitted). In other words:
[T]o avoid being impliedly preempted under Buckman, a claim must rely on traditional state tort law . . . . [T]he conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law – and that would give rise to liability under state law even if the FDCA had never been enacted.
Riley v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009) (internal quotation
Here, Schedin’s claim for punitive damages implicates evidence that Ortho-
McNeil took actions to mislead the FDA, such as the design and administration of the
Ingenix study. (See Goldser Aff., Ex. 1-6, 08-MDL-1943 (Docket No. 1651) (a study
alleged by Schedin to have been constructed by Ortho-McNeil to find no greater tendon
toxicity of Levaquin as compared to other fluoroquinolones).) However, the claims do
not hinge on a defrauding of the FDA. Defrauding the FDA is not a necessary finding
for any tort claims relevant to this litigation under Minnesota law. Further, punitive
damages can only be recovered if “plaintiff[ has] established the requisite kind of actual
or compensatory damages . . . .” Jacobs v. Farmland Mut. Ins. Co., 377 N.W.2d 441,
446 (Minn. 1985); see alsoUnited Prairie Bank-Mountain Lake v. Haugen Nutrition & Equip., LLC,782 N.W.2d 263, 273 (Minn. Ct. App. 2010) (“A claim for punitive
damages is not an independent claim.”). Therefore, punitive damages claims under
Minnesota law, by their very nature, rely on the existence of a state tort law claim. As a
result, the Court finds Buckman inapplicable to the instant case.
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In sum, the Court finds Ortho-McNeil has not demonstrated it was “physically
impossible” to comply with state law regarding adequate warnings and the FDCA. Even
if it could not have instituted a black box warning, Ortho-McNeil could have requested
one, and even if it could not have altered the “[i]ndications and usage” section of the
label to include comparative data, it could have applied for a waiver from that
requirement. It is also not clear that the type of data at its disposal was inadequate to
alter the “[w]arnings and precautions” section of the label, even without an “adequate and
well controlled study.” The Court finds unavailing the argument that the class
designation of Levaquin left Ortho-McNeil unable to supplement the mandated class
label, in the face of abundant evidence that other manufacturers have supplemented class
labels in numerous other instances, including Levaquin itself. Finally, Ortho-McNeil has
proffered no evidence that other methods of warning physicians, such as “Dear Doctor”
letters, targeted meetings with sales representatives, or other techniques short of label
changes were “physically impossible” such that the claims against it are pre-empted.
Further, the specific type of pre-emption articulated in Buckman is not applicable
to the punitive damages claim here where the claim does not hinge on a defrauding of the
FDA. Evidence of potential fraud committed on the FDA is simply a portion of
Schedin’s evidence offered to support the punitive damages claim. The Motion for
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Based on the foregoing, and the records, files, and proceedings herein, IT IS HEREBY ORDERED that Defendant’s Motion for Judgment as a Matter of Law
[Docket No. 149] is DENIED.
Quality Assurance Workgroup 2008-2009 This report is printed on recycled paper with at least 10 percent post-consumer waste. Table of Contents Quality Assurance Workgroup Members . 1 Introduction. 2 Current Policy . 3 Quality Assurance Workgroup . 4 Introduction/Overview. 4 Field Services Peer Driven Model . 5 Institutions Peer Driven Model. 5 Conclusions. 5 Introduction
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